Spermotrend in the Treatment of Male Infertility | NCT00975117

Studies
Spermotrend in the Treatment of Male Infertility

NCT00975117

Sponsor

Catalysis SL

Status

Completed

Last Update Posted

Mar 8, 2011Estimated

Enrollment

86Estimated

Phase

Phase 3

Conditions

Male Infertility

Interventions

Placebo
Spermotrend

Countries

Cuba

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Sep 10, 2009

First Submission Date that Met QC Criteria

Sep 10, 2009

First Posted Date

Sep 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2011

Last Update Posted Date

Mar 8, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether the administration of the dietary supplement Spermotrend improves spermatogenesis parameters in subjects with male infertility unrelated to major testicular conditions. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks. The estimated number of males with infertility to be recruited and randomized for the study is 86.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

86Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Dietary Supplement: Placebo
Spermotrend	Experimental		Dietary Supplement: Spermotrend

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Dietary Supplement	One Placebo tablet (Orally administered) twice a day, for 12 weeks.	Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Parameters of seminal analysis at weeks 24		24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Fertilization achievement		24 weeks
Presence of mild or severe adverse effects		24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male infertility unrelated to major testicular conditions
Must have at least one altered seminal parameter.
Signed informed consent

Exclusion Criteria:

Hydrocele, varicocele, orchitis, epididymitis, irradiation or Chemotherapy.
Previously treated and cured testicular condition.
Non-transmissible chronic diseases
Use of antioxidant agents within 6 months.
Use of vitamins within 6 months.
Use of anti-inflammatory drugs within 6 months.
Use of hormones prescribed by an andrologist within 6 months
Positive serology/HIV
Leukocytospermia

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Miguel Aguilar Charara, MD	"Ramón González Coro" Gynecologic and Obstetric Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
"Ramón González Coro" Gynecologic and Obstetric Hospital		Havana	La Habana	10400	Cuba

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35506389	Derived	de Ligny W, Smits RM, Mackenzie-Proctor R, Jordan V, Fleischer K, de Bruin JP, Showell MG. Antioxidants for male subfertility. Cochrane Database Syst Rev. 2022 May 4;5(5):CD007411. doi: 10.1002/14651858.CD007411.pub5.

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007246	Infertility